Global biotechnology company Biogen announced submission of a Biologics License Application with the U.S. Food and Drug Administration for regulatory approval of aducanumab on July 8. Aducanumab is an investigational biologic medication for early Alzheimer’s disease developed in partnership with Japanese pharmaceutical company Eisai. Biogen is headquartered in Switzerland.

If approved, aducanumab would represent a long-awaited major pharmaceutical breakthrough – the world’s first treatment to slow the clinical progression of Alzheimer’s disease. 

While existing medications such as Aricept and Namenda treat the symptoms of Alzheimer’s cognitive decline, such therapies do not alter the underlying pathophysiology trajectory of the disease.

"This drug may potentially have a huge impact, in terms of societal cost and in terms of patients' ability to pay co-pays over a long period of time," Dr. Howard Fillit, founding executive director of the Alzheimer's Drug Discovery Foundation, told MedPage Today. "We're talking potentially millions of people on a relatively expensive drug on a monthly basis. It's going to be a very big payer decision."

The development of aducanumab has been marked by fits and starts, according to a MedPage Today report. In March 2019, two parallel trials of aducanumab in patients with early stage and mild Alzheimer’s were terminated when an analysis indicated that aducanumab was unlikely to outperform a placebo. Just months later in October 2019, Biogen reversed its previous position and said that a review of previously unavailable data from one of the trials indicated that aducanumab actually did reduce cognitive decline due to Alzheimer’s.

Compared with conventional medications made from chemical substances, biologics are much more molecularly complex and considerably more costly to produce because they are derived from living sources such as yeast, bacteria, animals or humans, typically through the use of biotechnology and other cutting-edge methods. Despite costing an estimated 22 times more than conventional drugs on average, biologics are one of the fastest-growing types of prescription drugs. Biologics are administered by injection or intravenous infusion.

The FDA was given 60 days to decide whether to accept the aducanumab review application. Biogen expects to learn whether the application was granted Priority Review status upon acceptance.

According to the Alzheimer’s Association, Alzheimer’s affects more than 47 million individuals worldwide, including more than 5 million Americans. Alzheimer’s is the sixth-leading cause of death in the United States. The incidence of Alzheimer’s is on the rise, and the number of affected Americans is anticipated to reach 14 million by 2050.